check_circleStudy Completed

Carcinoma, Renal Cell

Bayer Identifier:

11515

ClinicalTrials.gov Identifier:

NCT00661375

EudraCT Number:

Not Available

EU CT Number:

Not Available
BAY43-9006 Phase II study for Renal cell carcinoma

Trial purpose

To evaluate efficacy, safety, and pharmacokinetics of BAY 43-9006 in patients with unresectable and/or metastatic renal cell cancer (RCC) who have failed at least one cytokine containing regimen.

Key Participants Requirements

Sex

Both

Age

18 Years
  • - Patients who suffer from unresectable and/or metastatic, measurable RCC histologically or cytologically documented.
    - Patients with rare subtypes of RCC, such as pure papillary cell tumor, mixed tumor containing predominantly sarcomatoid cells, Bellini carcinoma, medullary carcinoma, or chromophobe oncocytic tumors, are excluded from study participation.


  • - More than three regimens of previous treatment for RCC

Trial summary

Enrollment Goal
131
Trial Dates
November 2004 - March 2006
Phase
Phase 2
Could I Receive a placebo
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Sapporo City General HospitalSapporo, 060-8604, Japan
Completed
Hokkaido Cancer CenterSapporo, 003-0804, Japan
Completed
Sunagawa City Medical CenterSunagawa, 073-0196, Japan
Completed
Akita University HospitalAkita, 010-8543, Japan
Completed
National Cancer Center Central HospitalTokyo, 104-0045, Japan
Completed
Keio University HospitalTokyo, 160-8582, Japan
Completed
Tokyo Women's Medical University HospitalTokyo, 162-8666, Japan
Completed
Nippon Medical School HospitalTokyo, 113-8603, Japan
Completed
Tokyo Women's Medical University Medical Center EastTokyo, 116-8567, Japan
Completed
Chiba Cancer CenterChiba, 260-0801, Japan
Completed
Chiba University HospitalChiba, 260-8677, Japan
Completed
Saitama Medical School HospitalIrima-gun, 350-0495, Japan
Completed
Isesaki Municipal HospitalIsesaski, 372-0817, Japan
Completed
Tochigi Cancer CenterUtsunomiya, 320-0834, Japan
Completed
Tsukuba University HospitalTsukuba, 305-8576, Japan
Completed
Sapporo Medical University HospitalSapporo, 060-8543, Japan
Completed
Hokkaido University HospitalSapporo, 060-8648, Japan
Completed
Iwate Medical University HospitalMorioka, 020-8505, Japan
Completed
Tohoku University HospitalSendai, 980-8574, Japan
Completed
Miyagi Cancer CenterNatori, 981-1293, Japan
Completed
Yamagata University HospitalYamagata, 990-9585, Japan
Completed
University of Tokyo HospitalTokyo, 113-8655, Japan
Completed
Teikyo University HospitalTokyo, 173-0003, Japan
Completed
Asahi Central HospitalAsahi, 289-2511, Japan
Completed
National Defense Medical College HospitalTokorozawa, 359-8513, Japan
Completed
Gunma University HospitalMaebashi, 371-8511, Japan
Completed
Nagoya University HospitalNagoya, 466-8560, Japan
Completed
Niigata University Medical and Dental HospitalNiigata, 951-8520, Japan
Completed
Osaka University HospitalSuita, 565-0871, Japan
Completed
Kyoto Medical University HospitalKyoto, 602-8566, Japan
Completed
Hamamatsu University HospitalHamamatsu, 431-3192, Japan
Completed
Shizuoka Cancer CenterSunto, 411-8777, Japan
Completed
University of Yamanashi HospitalNakakoma, 409-3898, Japan
Completed
Osaka Medical Center for Cancer and Cardiovascular DiseasesOsaka, 537-8511, Japan
Completed
Kinki University HospitalOsakasayama, 589-8511, Japan
Completed
Kyoto University HospitalKyoto, 606-8507, Japan
Completed
Mie University HospitalTsu, 514-8507, Japan
Completed
Kurashiki Central HospitalKurashiki, 710-8602, Japan
Completed
Yamaguchi University HospitalUbe, 755-8505, Japan
Completed
Tokushima University HospitalTokushima, 770-8503, Japan
Completed
Kagawa University HospitalKita, 761-0793, Japan
Completed
Kyushu University HospitalFukuoka, 812-8582, Japan
Completed
Harasanshin HospitalFukuoka, 812-0033, Japan
Completed
Kurume University HospitalKurume, 830-0011, Japan
Completed
Nagasaki University HospitalNagasaki, 852-8501, Japan
Completed
Nara Medical University HospitalKashihara, 634-8522, Japan
Completed
Japanese Red Cross Wakayama Medical centerWakayama, 640-8558, Japan
Completed
Wakayama Medical University HospitalWakayama, 641-8510, Japan
Completed
Okayama University HospitalOkayama, 700-8558, Japan
Completed
Shikoku Cancer CenterMatsuyama, 791-0280, Japan
Completed
Kagoshima University HospitalKagoshima, 890-8520, Japan

Primary Outcome

  • Tumor response rate
    date_rangeTime Frame:
    Tumor measurements: every 6 weeks for the first 24 weeks (or the time of evaluation as progression, whichever is earlier) and every 8 weeks thereafter.
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Time to progression
    date_rangeTime Frame:
    Tumor measurements: every 6 weeks for the first 24 weeks (or the time of evaluation as progression, whichever is earlier) and every 8 weeks thereafter.
    enhanced_encryption
    Safety Issue:
    no
  • Proportion of patients with CR and PR according to the criteria of General Rule for Clinical and Pathological Studies on Renal Cell carcinomaCR and PR rate according to General Rule for Clinical and Pathological Studies on Renal Cell carcinoma
    date_rangeTime Frame:
    Tumor measurements: every 6 weeks for the first 24 weeks (or the time of evaluation as progression, whichever is earlier) and every 8 weeks thereafter.
    enhanced_encryption
    Safety Issue:
    no
  • Time to death
    date_rangeTime Frame:
    At the time of death
    enhanced_encryption
    Safety Issue:
    no
  • Overall response duration and time to objective response
    date_rangeTime Frame:
    Tumor measurements: every 6 weeks for the first 24 weeks (or the time of evaluation as progression, whichever is earlier) and every 8 weeks thereafter.
    enhanced_encryption
    Safety Issue:
    no
  • Overall disease control rate
    date_rangeTime Frame:
    Tumor measurements: every 6 weeks for the first 24 weeks (or the time of evaluation as progression, whichever is earlier) and every 8 weeks thereafter.
    enhanced_encryption
    Safety Issue:
    no
  • FACT-G and FKSI
    date_rangeTime Frame:
    Screening visit (within -14 days), every 6 weeks for the first 24 weeks and every 8 weeks thereafter.
    enhanced_encryption
    Safety Issue:
    no

Trial design

Phase II study of BAY 43-9006 in Japanese patients with Renal cell carcinoma
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

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